Good Documentation Guideline (Chapter <1029> USP)
Duration : 60 Minutes
Dr. Afsaneh Motamed Khorasani,
Dr. Afsaneh Motamed Khorasani, PhD, is a Medical and scientific Affairs expert and a Senior Scientist with a strong background in biomedical science and clinical trial/research. She has a tenured and diverse range of experience in medical affairs, basic and industrial clinical research and develop Read more
This webinar will familiarize participants with USP Chapter <1029> on good documentation guidelines. This session will wrap up the general concept and will provide information as to what needs to be documented in certain records.
Course Objective:
Good Documentation Practices (GDP) is a critical and essential part of a regulated environment (pharmaceutical and medical device manufacturing, R&D, laboratories and clinical trials). Compliance with GDP ensures an auditable account of work. It ensures integrity and control of documents and is a key requirement for a developed quality system.
This training session will cover the US Pharmacopeia General Chapter <1029> and all aspects of GDP including practices for writing and correcting documentation.
This webinar will familiarize participants with USP Chapter <1029> on good documentation guidelines. This session will wrap up the general concept and will provide information as to what needs to be documented in certain records.
Course Outline:
• History of the chapter as to how and why it was created
• Purpose of development of this chapter
• Chapter outline:
o Principles of Good Documentation
o Data collection & recording
o Different types of GMP Documents:
o Laboratory records
o Equipment-related documentation
o Deviations and investigations
o Batch records
o Certificate of Analysis (C of A)*
o Standard Operating Procedure (SOP)*
o Protocols & reports*
o Analytical procedures*
o Training documentation
• Retention of documents
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
GDP's are meant for use in the production and control of Active pharmaceutical ingredients (APIs), Medical devices, Excipients, Pharmaceutical products, Labs, Dietary supplements and Food ingredients. The following titles will benefit:
• Regulatory
• Compliance
• Audit
• Quality
• R&D
• Scientists
• Documentation and Validation
• Clinical Research
• Lab Managers
• Engineering and Manufacturing
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
